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Completed

NCT Number: NCT05769257

A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation

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Key information

Conditions

Ureter Injury

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. David's North Austin Medical Center, Austin, Texas, United States

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About this study

Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects between the ages of 18 and 75, inclusive
  • Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging

Exclusion criteria

  • Subject is pregnant or nursing
  • Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Subject has any of the following screening laboratory values:
  • eGFR < 60 mL/min/1.73 m^2
  • Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
  • Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
  • Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
  • Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
  • Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.

Treatment and study plan

IS-001

Drug

Intravenous injection of IS-001 investigational drug

Primary outcomes

  1. Evaluate ureter visualization by Independent Reader

    Time frame: 10 minutes after first IS-001 injection during surgery

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  2. Evaluate ureter visualization by Independent Reader

    Time frame: 30 minutes after first IS-001 injection during surgery

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  3. Evaluate ureter visualization by Independent Reader

    Time frame: 45 minutes after first IS-001 injection during surgery

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  4. Evaluate ureter visualization by Independent Reader

    Time frame: 10 minutes after second IS-001 injection during surgery

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  5. Evaluate ureter visualization by Independent Reader

    Time frame: 30 minutes after second IS-001 injection during surgery

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  6. Evaluate ureter visualization by Independent Reader

    Time frame: 45 minutes after second IS-001 injection during surgery

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

Secondary outcomes

  1. Evaluate ureter visualization by Intra-operative surgeon

    Time frame: 10 minutes after first IS-001 injection during surgery

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  2. Evaluate ureter visualization by Intra-operative surgeon

    Time frame: 30 minutes after first IS-001 injection during surgery

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  3. Evaluate ureter visualization by Intra-operative surgeon

    Time frame: 45 minutes after first IS-001 injection during surgery

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  4. Evaluate ureter visualization by Intra-operative surgeon

    Time frame: 10 minutes after second IS-001 injection during surgery

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  5. Evaluate ureter visualization by Intra-operative surgeon

    Time frame: 30 minutes after second IS-001 injection during surgery

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  6. Evaluate ureter visualization by Intra-operative surgeon

    Time frame: 45 minutes after second IS-001 injection during surgery

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

  7. Ureter Delineation Efficacy as Length of Line Drawn

    Time frame: 10 minutes after first IS-001 injection during surgery

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  8. Ureter Delineation Efficacy as Length of Line Drawn

    Time frame: 30 minutes after first IS-001 injection during surgery

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  9. Ureter Delineation Efficacy as Length of Line Drawn

    Time frame: 45 minutes after first IS-001 injection during surgery

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  10. Ureter Delineation Efficacy as Length of Line Drawn

    Time frame: 10 minutes after second IS-001 injection during surgery

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  11. Ureter Delineation Efficacy as Length of Line Drawn

    Time frame: 30 minutes after second IS-001 injection during surgery

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  12. Ureter Delineation Efficacy as Length of Line Drawn

    Time frame: 45 minutes after second IS-001 injection during surgery

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  13. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 10 minutes after first IS-001 injection during surgery

    Fluorescent intensity of ureter evaluated as signal to background

  14. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 30 minutes after first IS-001 injection during surgery

    Fluorescent intensity of ureter evaluated as signal to background

  15. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 45 minutes after first IS-001 injection during surgery

    Fluorescent intensity of ureter evaluated as signal to background

  16. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 10 minutes after second IS-001 injection during surgery

    Fluorescent intensity of ureter evaluated as signal to background

  17. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 30 minutes after second IS-001 injection during surgery

    Fluorescent intensity of ureter evaluated as signal to background

  18. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 45 minutes after second IS-001 injection during surgery

    Fluorescent intensity of ureter evaluated as signal to background

  19. Safety 12-Lead EKG Change from Baseline

    Time frame: 6 hours after first IS-001 injection post surgery

    12-Lead EKG change from baseline in QTc

  20. Incidence of abnormal blood work in tests results

    Time frame: Before same-day discharge or 24 hours after first IS-001 injection post surgery

    Safety hematology complete blood count laboratory assessments Change from Baseline

  21. Incidence of abnormal blood work in tests results

    Time frame: Before same-day discharge or 24 hours after first IS-001 injection post surgery

    Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline

  22. Incidence of abnormal blood work in tests results

    Time frame: 14 days post surgery

    Safety hematology complete blood count laboratory assessments Change from Baseline

  23. Incidence of abnormal blood work in tests results

    Time frame: 14 days post surgery

    Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline

  24. Incidence of abnormal urinalysis results

    Time frame: 14 days post surgery

    Routine urinalysis laboratory assessment change from baseline

  25. Safety Adverse Events Monitoring

    Time frame: 14 days post surgery

    Drug related adverse events monitoring through 14-days

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Phase 2 Multi-Center Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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